A Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients with Acute Ischemic Stroke (NCT06700824) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients with Acute Ischemic Stroke
France60 participantsStarted 2025-02
Plain-language summary
The MaTRISS 2 study is a phase 2 randomized, double-blinded and placebo-controlled trial aimed at recruiting 60 subjects (30 placebo and 30 active) from 15 stroke centers in France. The main objective will be to assess the efficacy of OTR4132-MD in patients with anterior ischemic stroke after endovascular thrombectomy. One dose will be tested (2 mg) against placebo. The main outcomes will be NIHSS (neurological score) at 24 hours, rate of intracranial hemorrhages at 24 hours, MRI lesion volume at 3 months and neurological scores at 3 months.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age between 18 and 85 years
✓. Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI).
✓. Occlusion of anterior circulation i.e. carotid artery (ICA) or proximal middle cerebral artery (MCA) (M1 and/or M2 segment)
✓. Endovascular thrombectomy (with or without previous intravenous thrombolysis)
✓. Recanalization confirmed by angiography after endovascular treatment: TICI grade 2b - 3
✓. NIHSS (National Institute of Health Stroke Scale/Score) ≥ 11
✓. Pre-stroke modified Rankin Score (mRS): 0 or 1
✓. Patient\* or legally authorized representative (family member or trusted person if patient unable to give consent) or independent physician (if patient unable to give consent and if an authorized representative cannot be reached) has signed informed consent.
Exclusion criteria
✕
What they're measuring
1
Baseline-Adjusted 24-Hour NIHSS
Timeframe: 24 hours
Trial details
NCT IDNCT06700824
SponsorOrgan, Tissue, Regeneration, Repair and Replacement